BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H2 TIBIAL ASSEMBLY

    MDR report key: 10721998 · Received October 22, 2020

    Report

    Report Number
    3012104767-2020-00002
    Event Type
    Injury
    Date Received
    October 22, 2020
    Report Date
    October 23, 2020
    Manufacturer
    DT MEDTECH, LLC
    Product Code
    HSN
    PMA / PMN Number
    K171004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY TO REPLACE H2 TIBIAL ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181295 HINTERMANN SERIES H2 TIBIAL ASSEMBLY TOTAL ANKLE REPLACEMENT HSN DT MEDTECH, LLC 422805 AAAQX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention